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Implementation of ICH Q12 Guideline

Delivery Mode: Webinar

ISPE Team Assists Training Health Canada with Implementation of ICH Q12 Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Regulatory Background

International Council for Harmonisation’s (ICH) guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12) provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of ICH’s Q12 Guideline will promote innovation and continual improvement in the biopharmaceutical and pharmaceutical sectors and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain management. It will allow regulators (assessors and inspectors) to better understand the firm’s Pharmaceutical Quality Systems (PQSs) for the management of post-approval CMC changes.

The guideline was adopted by ICH regulators in November 2019 and is in the process of implementation by ICH member regulators. ICH Q12 does incorporate concepts such as established conditions (ECs), post approval change management protocols (PACMP) and product lifecycle management (PLCM) and some of these concepts are new to regulatory agencies.

ISPE Q12 Implementation Team

ISPE’s Product Quality Lifecycle Implementation (PQLI)® initiative was created to provide guidance on practical implementation of the concepts described in ICH guidelines, focusing on Q8, Q9, Q10, Q11 and Q12 to help ensure product quality throughout a product lifecycle, leading to continual product improvement.

Under the PQLI umbrella an ICH Q12 Implementation Team was established with a focus on developing a body of knowledge to assist industry with global implementation of Q12. Major outputs in the past 2 years have been two publications in Pharmaceutical Engineering (PE) – on in May/June 2020 and another in September/October 2021, and a webinar in 2021. This webinar, Challenges and Success of ICH Q12 Related Submissions is available to view on demand and includes a presentation from FDA -

Implementation in Canada

As a major part of implementation in Canada, the agency, Health Canada (HC) issued in July 2021 a revised series of draft guidances for Post-Notice of Compliance (NOC) Changes i.e. post approval changes, with a deadline for stakeholder comments by end of October 2021. As a continuing part of HC’s Q12 implementation, HC announced in November 2021 an opportunity for a limited number of applicants to participate in two pilot programs, one of which is an ICH Q12 Established Conditions and Post Approval Change Management Protocol Pilot Program.

In order to prepare HC reviewers for the receipt of applications for the Q12 pilot and to assist with eventual full implementation of ICH Q12 in Canada, HC asked ISPE if it could assist with some training based on case studies and experiences in the FDA pilot on established conditions. These case studies had been included in the 2021 PE article and webinar. ISPE agreed and an Q12 Implementation sub team was established with the aim of delivering the training before reviewers were tasked with reviewing applications. This series of videos were taken from ISPE's training session with Health Canada.

Course Modules

Module 1

  • Introduction and Workshop Objectives
  • Presentation: Summary of why ICH Q12 was needed
  • Presentation: Description of pharmaceutical company change management system
  • Plenary Discussion on change management system
  • Presentation: Introduction to Q12

Module 2

  • Introduction to Established Conditions and Case Studies
  • Presentation: Established Conditions, Case Study 1 to small molecule reviewers
  • Synthetic Drug substance process
  • Presentation: Established Conditions, Case Study 2 to biotech reviewers
  • Large molecule drug substance process
  • Presentation: Established Conditions, Case Study 3 to all reviewers
  • Analytical method
  • Case study work on choosing ECs

Module 3

  • Presentation of PLCM Document (ICH material)
  • Presentation and case study work on developing and reviewing PLCMs.
  • Presentation: Discussion of PLCM and the Canada-specific Certified Product Information Document (CPID) in the context of Lifecycle Management.

Module 4

  • Presentation on best practices for preparation of a post approval change management protocol (PACMP)
  • Practice review of mock PACMP documents
  • Close and any Next Steps

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Vice President, Quality and Regulatory Compliance
Novo Nordisk Inc.

Senior Director, Quality Operations/Environmental Health & Safety

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Amicus Therapeutics